Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075136
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/20/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75136ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75136_Verapamil%20Hydrochloride.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2021 | SUPPL-14 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/20/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |